Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease Progression?

March 20, 2017 updated by: Michal Guindy, Assuta Medical Center

Imaging After Stereotactic Radiosurgery for Brain Metastases or Primary Tumor Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease ?

PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details will be performed on set intervals to patients with brain tumor & brain metastases in order to try to optimize the study protocol, distinguish between pseudo-response to anti-angiogenic therapy and tumor progression, and most importantly try to distinguish between progressive tumor and treatment related effects.3 cohort of patients will be included in the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The multimodality approach for management of primary and secondary brain tumors includes surgery, radiotherapy and chemotherapy. Determination of an objective response to treatment relies on imaging findings (e.g. CT, MRI, PET).During the course of the disease patients with brain tumors often develop new or worsening contrast-enhancing lesions on routine follow-up imaging.These lesions may reflect tumor recurrence, treatment effect, or a combination of both. Discerning between tumor recurrence and treatment effect is clinically significant issue and a major challenge in neuro-oncology. Treatment-related effects exist within a spectrum, with "pseudoprogression" reflecting subacute and often transient injury, and "radiation necrosis" reflecting later and more permanent damage.The difficulty in differentiating tumor progression from treatment-related effects has serious implications for individual patient treatment decisions and prognosis as well as for clinical trial design and interpretation of results.

A contemporary hybrid scanner technology is capable of acquiring both metabolic information from PET and morphological and functional details from MRI. This new integrated technique opens new horizons for clinical and research evaluation of brain tumors and the associated treatment effects.

The aim of the current study is to use the combined data obtained by PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details in order to:

  1. Distinguish between progressive tumor and treatment related effects
  2. To identify pseudo-response to antiangiogenic therapy from tumor progression
  3. To optimize the study protocol of PET-MRI for future routine clinical application.

The study will include three cohorts of patients with brain tumors:

  1. Primary brain tumors:

    A cohort of 60 adult patients (age: 18-70) with newly diagnosed high grade gliomas (Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma) scheduled for a combined treatment with chemotherapy and radiotherapy. Patients will be eligible for the study immediately after receiving the pathological diagnosis and prior to any further treatment. These patients will undergo the PET-MRI scanning at 4 time points as follows:

    • 1st scan: after surgery or biopsy and before any further treatment
    • 2nd scan: will be performed up to 4 weeks after completing the combined radiotherapy and chemotherapy regimen.
    • 3rd and 4th scans: will follow with interval of 3 months between studies.
    • Additional scans will be performed by the decision of the investigators or when the patient is scheduled for antiangiogenic therapy

  2. Brain metastases treated with stereotactic radiosurgery (SRS):

    A cohort of 60 adult patients (age: 18-75) who are being followed after SRS treatment for brain metastases secondary to breast or lung cancer whose recent imaging showed signs of progression in at list one of the previously treated lesion. Progression will be determined by Response Assessment in Neuro-Oncology Criteria (RANO criteria) for brain metastases. Number of target lesions should not exceed 4 with size of lesions ranging between 5-40 mm. These patients will undergo the PET-MRI scanning at three time points as follows:

    • 1st scan: Following determination of progression of SRS treated lesion based on standard surveillance MRI
    • 2nd and 3rd scans: will be performed every 2 months after the first scan
    • Additional scans will be performed by the decision of the investigators
  3. Brain metastases not treated with SRS/radiotherapy

A cohort of 20 adult patients (age: 18-75) with a diagnosis of brain metastases secondary to human epidermal growth factor receptor 2 (HER2) positive breast cancer or anaplastic lymphoma kinase (ALK) or Epidermal Growth Factor Receptor (EGFR) gene mutant lung cancer who might be candidate for SRS treatment and in whom targeted therapy is selected instead. The size of the lesions should range between 5-40 mm. These patients will undergo the PET-MRI scanning at three time points as follows:

  • 1st scan: after the first documentation of brain metastases on standard MRI
  • 2nd and 3rd scans: will be performed every 2 months after the first scan
  • In case of progression and SRS treatment follow-up scanning will be performed every 2 months
  • Additional scans will be performed by the decision of the investigators

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject with glial brain tumors,
  • Subjects with metastatic brain tumors that were treated with stereotactic radiation (SRS), * Subjects with metastatic brain tumors which were not treated

Exclusion Criteria:

  • glial tumor with no histological diagnosis
  • non breast of lung metastasis
  • non compliance
  • unable to lay still during the scanning
  • mri non
  • renal failure/gadolinium sensitivity
  • less than 5 mm metastatic tumors
  • bleeding brain tumors
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PRIMARY BRAIN TUMOR (PBT)
patients with PBT (Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma), before treatment with radiation and chemotherapy.will be followed with PET MRI
Diagnostic test: PET MR
PET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals
Other: METASTATIC BT TREATED BY SRS

patients with lung or breast metastasis to brain treated by SRS in which at least one lesion showed deterioration by MR performed after treatment.

will be followed with PET MRI
Diagnostic test: PET MR
PET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals
Other: METASTATIC BT NOT TREATED BY SRS

patients with lung or breast metastasis to brain where the SRS treatment was postponed for clinical reasons (getting mutation information for targeted treatment) the lesion size measures 5-40 mm.

will be followed with PET MRI
Diagnostic test: PET MR
PET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distinguish between progressive tumor and treatment related effects
Time Frame: 1st scan: after surgery or biopsy and before any further treatment - 2nd scan: up to 4 weeks after completing the combined radiotherapy and chemotherapy regimen. - 3rd and 4th scans - 3 month interval apart
finding PET-MRI difference between progression and treatment effect correlating with clinical out come
1st scan: after surgery or biopsy and before any further treatment - 2nd scan: up to 4 weeks after completing the combined radiotherapy and chemotherapy regimen. - 3rd and 4th scans - 3 month interval apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Medical Center

Collaborators

Rabin Medical Center

Investigators

  • Principal Investigator: Michal Guindy, MD, Assuta Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 26, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022-16-ASMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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